Clovis’ sNDA for Rubraca Gets Priority Review in the U.S.

Clovis OncologyCLVS announced the FDA has granted priority review to its supplemental new drug application (sNDA) looking for label expansion of its marketed drug, Rubraca (rucaparib).

The sNDA is looking to expand Rubraca’s label as a maintenance treatment for patients with platinum-sensitive recurrent ovarian cancer regardless of a patient’s BRCA mutation status. With the FDA granting priority review, a response from the regulatory body is expected in Apr 6, 2018. Approval of the drug for this expanded indication will provide the company access to a wider population base of patients with ovarian cancer.

Notably, Rubraca is a PARP inhibitor, having received an accelerated approval in the United States in December 2016 for advanced ovarian cancer patients with deleterious BRCA mutation, previously treated with two or more chemotherapies.

Clovis’ shares are up almost 29.9% so far this year, significantly outperforming the industry’s 0.9% rally during the period.

The sNDA was submitted in October, based on promising data from the confirmatory phase III study, ARIEL 3, announced in June. Rubraca demonstrated a meaningful impact in delaying disease recurrence in advanced ovarian cancer patients, who are either BRCA mutant or HRD positive.

We remind investors that Rubraca as a monotherapy is also under review in the EU for treating advanced ovarian cancer. An opinion is expected later this month.

Clovis is also planning to file a marketing authorization application in early 2018 for maintenance treatment in the EU following the potential approval as monotherapy.

A potential approval in the EU and the label expansion in the United States are expected to boost the drug’s potential. It has generated sales of nearly $38.5 million in the first nine months of 2017 post its launch in December last year.

However, Clovis’ Rubraca is facing competition from other PARP inhibitors including Tesaro, Inc.'s TSRO Zejula and AstraZeneca's AZN Lynparza as both these drugs are also approved to treat ovarian cancer irrespective of the BRCA-mutation.

Meanwhile, the second phase III confirmatory study, ARIEL4, is evaluating Rubraca compared with chemotherapy on patients, who have failed two prior lines of therapy. Clovis is also looking to expand Rubraca’s label into additional indications like prostrate, breast and pancreatic cancers among others either as monotherapy or in combination with other agents.

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